Policy Uncertainty, Sequencing, and Cell Lines

Abstract

The circumstances surrounding the creation of the HeLa cell line are now well known. The best-selling book by Rebecca Skloot, The Immortal Life of Henrietta Lacks (Skloot 2010), detailed both the creation of the cell line and the associated ethical and social controversies. The Skloot book received a great deal of praise and media attention–which often used the book to surface a range of ethical issues associated with biomedical research (Nisbet and Fahy 2013). The recent sequencing and publication of the genome of one HeLA cell line (Landry et al., 2013) has further intensified public attention on the circumstances surrounding the Lacks case and the associated ethical challenges, particularly in relation to ownership and control of samples and data (Skloot 2013). While we should not over-interpret the story of the HeLa cell line as being emblematic of how research involving human tissue is conducted, it provides an opportunity to reflect on the profound and enduring lack of clarity that surrounds many relevant legal and ethical concepts (Callaway 2013). Given the advances in sequencing technology, the growing significance and investment in biobanking, and the push for open access to the results of scientific inquiry, it is essential that current policy uncertainties be acknowledged and addressed. Otherwise, we risk creating misconceptions, undermining public trust, and unwittingly derailing advances in the field. This article seeks to highlight two important issues in need of immediate policy attention, as underscored by the public response to the HeLa story: ownership and control of biological specimens, and obligations to third party relatives in genomic research. Much of the relevant media coverage associated with the Skloot book touched on specific issues of consent and ownership, as noted by Nisbet and Fahy in their interesting analysis of the significant popular culture response (Nisbet and Fahy 2013). The implied message seemed to be, rightly or not, that individuals should retain some degree of control over biological specimens that are removed from their bodies. The reaction to the 2013 publication of the genome sequence of a HeLa cell line and its data likewise implied a baseline expectation regarding the procurement of consent from biological relatives prior to releasing genome sequence data. (See box.) But are there clear existing legal and ethical norms that can be used to direct us on these key issues? In fact, despite decades of research involving human tissue and billions of dollars of investment, the law surrounding the ownership and control of human biological material remains remarkably uncertain (Charo 2006; Feldman 2011). There have been several highly relevant cases in the U.S.–such as the well-known cases of Moore v Regents of the University of California (1990), Greenberg v Miami Children’s Hospital Research Institute (2003), and Washington University v Catalona (2007) – but a definitive picture of who has a right to control samples remains elusive. While the law seems to reject the idea that individuals who contribute samples to research have a definitive property right to their contributed material, case law also affirms the idea that those individuals retain a degree of control, primarily in the form of the right to withdraw or to request destruction of the sample (Washington University v Catalona 2007). And, as highlighted by cases from other jurisdictions, such as the UK decision of Yearworth v. North Bristol NHS Trust (2009), courts seem willing to accept and rely on notions of property if, from the perspective of the court, the policy goals justify the approach. (Yearworth dealt with interest in reproductive material.) In Canada, there is case law, including jurisprudence from the Supreme Court of Canada, that suggests that individuals maintain a continuing interest in health information. In the case of McInerney v McDonald, for example, the court concluded that health information “is information that goes to the personal integrity and autonomy of the patient … [and] remains in a fundamental sense one’s own” (McInerney v McDonald 1992). With the availability of increasingly low-cost DNA sequencing technology, such as that used to sequence the genome of the HeLa cell line, this kind of jurisprudence increasingly seems pertinent to human cell research. Will human cells be viewed through the lens of the law as nothing more than receptacles of sensitive personal health information and thus subject to all the same rigorous consent and privacy norms (Burningham 2013)? And what, if any, interest do biological relatives have in the use of samples and publication of genetic data? Since genomic information is uniquely identifying and familial by nature, publication of an individual’s sequence has implications for that person’s biological relatives (Gymrek et al. 2013). It therefore seems like good policy to engage biological family members before making genome sequence data public–part